Suyog Pate
Summary
A highly skilled regulatory professional with extensive experience in global market submissions and processes, adept at navigating multiple therapeutic areas, drug development, and clinical studies. Demonstrates in-depth knowledge of CTA, PIP, and ODD applications, alongside a strong command of ICH, CMDh, EMA, and global registration requirements. Proficient in preparing high-quality CMC regulatory documents using diverse information sources. Known for commitment to quality and results, complemented by excellent problem-solving abilities and leadership skills. Career goals include advancing expertise in regulatory affairs to drive successful drug development initiatives globally.
Overview
17
17
years of professional experience
5
5
years of post-secondary education
Work history
Regulatory Affairs Associate Director
Aspeva
2024.07 - 2026.07
- Develop and execute global and regional regulatory strategy for drug development and clinical trials.
- Represent regulatory on core development functional teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into drug development, clinical programs and commercial strategy.
- Address complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRA functional team and GRA leadership.
- Oversee development of CTA, IND and IMPD dossiers, review and completion of documents for regulatory submissions.
- Lead preparation of briefing documents for health authority meetings and actively participating in review and updates of study protocols and investigator’s brochure (IB).
- Led correspondence with regulators, coordinated meeting requests, and facilitated in-house preparation for regulatory interactions.
- Managed project plans and timelines, ensuring appropriate prioritisation of projects and timely achievement of key goals.
- Monitored, analysed, and anticipated changes in regulatory environment, assessing impact on product and submission targets, and communicated necessary adjustments to strategies and content.
- Led and implemented Veeva RIM as per business requirements.
- Initiated Regulatory intelligence set up and quarterly updates to capture regulatory guidance updates relevant to business.
- Prepare and update SOPs as per business needs.
Global Regulatory Lead – Senior Manager
Pfizer
2021.08 - 2024.06
- Lead Global Regulatory Team and interact with other functions, regional leads and partners, in the preparation, review, and completion of documents for regulatory submissions.
- Develop and implement Global and regional regulatory strategies for development projects, clinical studies, manufacturing improvements and analyses risk verses benefit in regulatory strategies to ensure successful review by regulatory authorities.
- Ensure quality and timeliness of IND, NDA, MAA, CTA, PIP, and supplements filings, including query response submissions.
- Manage the preparation of registration packages for Global markets including US, Japan and responses to deficiency letters to ensure effective presentation and quality.
- Negotiate and influence submission data requirements and deliverable dates with regulatory authorities and internal technical teams.
- In conjunction with Global Regulatory Team, work with project teams to resolve complex project issues. Utilise regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of approvals.
- Acted as point of contact for regulatory agency interactions, preparing briefing packages and strategies for meetings, inspections, advisory committee meetings, and responses to agency letters.
- Provided strategic regulatory input to key development activities and documents, including clinical and nonclinical reports and summary documents, to align with regulatory expectations.
- Evaluated safety, labelling and CMC changes (Type II, IB and IA variations) and promotional materials for global regulatory impact, ensuring compliance with applicable regulations and market requirements.
- Maintain awareness of global regulatory legislation and assess its impact on marketing authorisations, business and product development programs.
- Provide training and mentoring to reportees and other regulatory staff.
Global Regulatory Affairs Manager
PRA Health Science (Takeda)
2018.02 - 2021.07
- Led global regulatory strategy for assigned therapeutic areas, coordinating and managing regional filing requirements to ensure compliance and timely submissions.
- Plan, manage and execute MAA/NDA filings and post approval activities in EMEA, CIS, LATAM, GCC, Sub-Saharan Africa and APAC regions.
- Achieved timely submission and approval of CMC and safety changes in all licensed countries to maintain product compliance and supply to markets.
- Strategies, manage and execute regulatory activities on products such as submission of variations, renewals, line extensions, labelling/safety updates, deficiency letter response for new and marketed products in EU and EM.
- Lead and provide functional inputs to Global Regulatory Team to define and achieve set goals and raise or participate in topics/proposals to Global Product Team from regulatory perspective.
- Collaborated with project and functional teams to ensure appropriate data generation for compilation and submission in line with market requirements.
- Direct communication with regulatory authorities to facilitate productive dialogue on assigned products.
- Interface with regulatory counterparts in affiliate companies to support regulatory activities on assigned products.
- Prepared, reviewed, and coordinated ACO and PSUR submissions globally to maintain regulatory compliance.
- Assessed regulatory implications of change requests to ensure compliance with guidelines.
- Liaised with external companies to support out-licensing and divestment activities.
- Provided training, coaching, and mentoring to reportees and other regulatory staff.
Regulatory Affairs Assistant Manager
Glenmark Pharmaceuticals Europe Limited, UK
2015.06 - 2018.01
- Management of EU applications (CP, DCP, MRP, ru-MRP and national submissions) including responses to requests for further information from competent authorities and the successful close-out of the national licensing phase of the european regulatory procedures.
- Generation of high-quality EU regulatory submissions to the company’s target markets to deliver a successful and timely portfolio of MA approvals to support the company’s business activities.
- Regulatory strategy planning for in-house procedures, in-licensing and out-licensing products.
- Perform due diligence on the dossiers for new submissions and for in-licensing activities to ensure that the dossier is in line with the EU requirements for range of therapeutic areas.
- Life cycle maintenance of products including preparation and submission of variations, renewals, PSURs, change of ownership and change control advice as well as managing regulatory activities in preparation for product launches to agreed business deadlines.
- Developed effective interactions with project and functional teams in Europe and India, ensuring generation and compilation of appropriate data in accordance with EU requirements.
- Preparation of product information for new submissions and review of prepared mock-ups/artwork in accordance with the national regulations.
- Develop contact and follow up with health authorities for new and ongoing procedures to speed up the approval process.
- Liaised with BD team and external companies on in-licensing and out-licensing activities, reviewing legal contracts from a regulatory perspective.
- Liaise with BD and country manager for launch plans and prepare appropriate regulatory strategy to achieve set goals.
- Attending scientific meetings with health authorities for advice on critical projects for the company.
- Provide support to licensing activity in non-EU countries.
- Train and provide support to reportees, junior staff members and contractors as required.
- Prepared SOPs for internal and business-related activities to streamline regulatory processes.
Regulatory Affairs Officer
TEVA Ltd. (Europe), UK
2013.09 - 2015.05
- Work closely with R&D sites and business units, supporting the preparation, compilation, review and submission of high-quality regulatory dossiers, response documents and post approval documentation in accordance with EU requirements, legislation, guidance’s and company SOP’s.
- Prepared Module-1 and Module-2 documentation and reviewed Module-3 documents for initial submission, ensuring compliance with regulatory standards.
- Preparation and submission of Type IA, IB & Type II variations and follow up with health authorities for status of the application.
- Perform regulatory activities for both generic submissions and launch critical post approval activities for DCP, MRP & CP procedures.
- Prepared and reviewed SmPC, PIL, and labelling for new submissions according to QRD guidelines, liaising with artwork department for patient user testing and mock-ups to enhance submission quality.
- Preparation of validation responses and liaising with health authorities for validation of the procedure and performing linguistic review for CP procedures.
- Liaising within Pharmacovigilance department for generation of risk management plan and safety related variations.
- Strategy planning, preparation and submission of repeat use MRP.
- Provides support to the Product Lifecycle Management with respect to the tracking of ongoing activities and planning future submissions and ensuring that the regulatory records are maintained in accordance with the Document Management System.
- Summarize and tabulate Non-clinical and Clinical module documents.
- Collaborated with team members on various projects, providing support based on project needs to facilitate successful outcomes.
Formulation Development Scientist
GSK R&D, Ware, UK
2011.07 - 2013.08
- Carry out formulation and development of DPI formulations from lab to pilot under cGMP conditions. Involved in phase-III product development.
- Developed and implemented technology transfer methods and conducted stability studies to ensure successful formulation development.
- Developed novel drug candidates through formulation techniques.
- Maintain precise experimental records, perform and report necessary documentation to support regulatory submission such as NDA and MAA.
- Compiled, reviewed, and submitted high-quality data to support regulatory dossiers and respond to Health Authorities' queries in line with in-house standards and current legislation.
- Liaise with regulatory department to achieve submission time lines and maintain compliance.
- Preparation of documentation to go in CMC section of GSK's IMMS system.
- Documented deviations and change controls to ensure compliance with quality standards.
- Production of, or contribution to, departmental quality documentation including SOPS, batch documentation, validation protocols & reports.
- Gathering, analysing and comparing data from different campaigns.
- Data and transcription checking of file content against source data.
- Record maintenance and archiving of regulatory documents.
- Manages & contributes to one or more projects in support of development plans.
- Prepared and maintained indexes for regulatory submissions to facilitate compliance and streamline documentation processes.
Formulation Scientist
Pfizer Global Research and Development, Kent, UK
2009.09 - 2011.06
- Developed and formulated dry powder inhaler formulations of novel candidates, ensuring processability, product performance, and stability to achieve formulation and process development goals.
- Conducted literature searches, designed experiments, prepared protocols and reports, and executed development trials and stability studies to support formulation objectives.
- Pre-clinical and clinical phase development of dosage forms.
- Assisted in scaling up lead formulations, facilitating toxicological and clinical assessments.
- Physical and analytical characterisation of prepared formulations through use of established procedures as well as interpretation of out-sourced and in-sourced results.
- Operated in GMP and GLP environments to ensure compliance with regulatory standards.
Education
M.Sc. - Formulation Science
University of Greenwich
Greater London 2007.01 - 2009.01
Bachelor of Pharmacy - undefined
University of Pune
India 2004.01 - 2007.01
Skills
- Regulatory skills
- Regulatory compliance knowledge
- Regulatory strategy
- Regulatory application expertise
- Global market submissions
- CMC regulatory documentation
- Therapeutic area expertise
- Commitment to quality
- Problem-solving
- Presentation and leadership
- Behavioural traits
References
Referee details available upon request.
Timeline
Regulatory Affairs Associate Director
Aspeva
2024.07 - 2026.07
Global Regulatory Lead – Senior Manager
Pfizer
2021.08 - 2024.06
Global Regulatory Affairs Manager
PRA Health Science (Takeda)
2018.02 - 2021.07
Regulatory Affairs Assistant Manager
Glenmark Pharmaceuticals Europe Limited, UK
2015.06 - 2018.01
Regulatory Affairs Officer
TEVA Ltd. (Europe), UK
2013.09 - 2015.05
Formulation Development Scientist
GSK R&D, Ware, UK
2011.07 - 2013.08
Formulation Scientist
Pfizer Global Research and Development, Kent, UK
2009.09 - 2011.06
M.Sc. - Formulation Science
University of Greenwich
2007.01 - 2009.01
Bachelor of Pharmacy - undefined
University of Pune
2004.01 - 2007.01